Viridian Therapeutics has scored an FDA approval for Lumvoa to treat thyroid eye disease (TED), triggering competition with Amgen’s blockbuster Tepezza, which is the only other medicine on the market for the eye-bulging autoimmune condition.
The FDA nod applies to adults with active or chronic TED, making it the first approved therapy in its anti-insulin-like growth Factor 1 receptor (IGF-1R) class to carry labeling that includes data in both active and chronic TED, the company pointed out.
In addition to this advantage, Viridian hopes to count on a convenience edge over Amgen’s IGF-1R Tepezza.
“We have a shorter infusion time—30 to 40 minutes versus 60 to 90 minutes and we only have five infusions versus eight,” Steve Mahoney, Viridian’s CEO said in an interview with Fierce. “What’s critical there, is we have a 12-week treatment period versus a 21-week period for the currently approved one.”
Viridian also is touting Lumvoa’s rapid treatment effect, as a majority of patients have gotten relief for their proptosis (eye-bulging) after just one infusion. The treatment also has been effective in correcting the diplopia (double-vision) that often accompanies TED. Lumvoa is the first approved product for TED to show a statistically significant effect in both diplopia response and complete resolution in active and chronic TED, the company said.
While Lumvoa brings the same mechanism of action as Tepezza, it is a “fundamentally different compound,” according to Viridian chief medical officer Radhika Tripuraneni, M.D.
“They work at the preclinical level or the biological level a little bit differently,” Tripuraneni said in the interview, describing Tepezza as a “partial antagonist,” compared to Lumvoa, which has a different binding mechanism giving it a “more full antagonism approach.”
The nod was supported by two phase 3 trials which showed a 12-week course of Lumvoa provided statistically significant and clinically meaningful improvements at week 15 across each of the key signs and symptoms of the disorder.
"We believe Lumvoa has the potential to capture meaningful market share from Tepezza, supported by its competitive clinical profile across both active and chronic TED populations, with potential for modest market expansion," William Blair analyst Lachlan Hanbury-Brown said in a note to investors, also warning that they "should have modest expectations for revenue in the second half of 2026," given the timelines for patients to be processed and gain reimbursement.
TED is an autoimmune condition which causes inflammation, impacting the muscles and tissue around the eyes. It is painful, as patients report the feeling of sand in their eyes. They also can get eyelid retraction where the eyelids can’t cover the eyeball. TED mostly strikes women in their 40s and 50s.
“You can think about how active that age-group is with respect to work, family, everyday living. These patients don’t like what they look like, the disfiguring, the bulging, the redness and the debilitating nature of it—the double-vision,” Mahoney said.
Lumvoa is the first approved product for Viridian. The Massachusetts-based biotech went public a decade ago as miRagen Therapeutics before acquiring privately-held Viridian in 2020 and taking on its name.
Viridian says it will launch Lumvoa immediately. The wholesale acquisition cost of Lumvoa for an average-sized patient of 75 kilos (165 pounds) is $450,000, which brings it in “parity” with Tepezza, Veridian chief commercial officer Tony Casciano on a “course of therapy basis,” meaning that five infusions of Lumvoa will cost roughly the same as eight of Tepezza.
In gearing up to market the treatment, Viridian has added roughly 100 sales reps and more than doubled its size to 400-plus employees since Mahoney took over in 2023. The company is in solid financial shape, as it closed the first quarter with $762 million in cash.
“This is a phenomenal team that has proven itself in the clinical development world and now we’re really excited to show what we can do commercially,” Mahoney said. “Our job is to get out there and educate.”
A month ago, Viridian linked up with Chinese manufacturing juggernaut WuXi Biologics on a five-year deal to be a “non-exclusive” supplier of Lumvoa, according to a regulatory filing.
Amgen, which acquired Tepezza in its $27.8 billion buyout of Horizon Therapeutics in 2023, has had difficulty boosting its sales, which peaked in 2022 at $1.97 billion in just its second full year on the market following its 2020 approval. Last year, the treatment generated $1.90 billion.
Amgen hopes to draw new patients to Tepezza with an on-body injector (OBI), which delivers treatment subcutaneously. In April, the company reported the success of a phase 3 trial of patients with moderate-to-severe TED which showed the OBI can provide comparable performance to its current route of administration.
Veridian hopes to counter the innovation with its own injected treatment for TED, elegrobart, which scored in a phase 3 trial earlier this year, but with results that did not impress investors, as study’s responder rate was 54% for the candidate compared to 18% for the placebo group.